Central Venous CatheterCAS-2NCT07014722
Contact Activation of Coagulation in Newly Inserted Central Venous Catheters
A study testing MERITMEDICAL Careflow™ Two-Lumen Central Venous Catheter, ARROW Two-Lumen Central Venous Catheter and ARROWg+ard Blue Plus® Two-Lumen Central Venous Catheter in people with Central Venous Catheter and Coagulation, run by Thomas Kander at 1 site in Sweden.
Trial summary
A central venous catheter (CVC) is a thin plastic tube placed into one of the body's large veins, typically in the neck or near the clavicle. CVCs are crucial for administering medications, fluids, and secure blood samples. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Catheter, Coagulation, Coagulation Activation
- What is being tested?
- MERITMEDICAL Careflow™ Two-Lumen Central Venous Catheter, ARROW Two-Lumen Central Venous Catheter and ARROWg+ard Blue Plus® Two-Lumen Central Venous Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSweden
- Study dates
- 10 Sep 2025to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria to be included in the study:
- Clinical indication for the placement of a two-lumen central venous catheter with length 150-160 mm.
- Age ≥18 years.
- Signed informed consent.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- Current use of anticoagulants or platelet inhibitors, except: Prophylactic low molecular weight heparin (LMWH), double prophylactic dose of LMWH, Acetylsalicylic acid (ASA).
- Prothrombin complex (pK/INR) outside the normal range (0.9-1.2), platelet count <50 × 10⁹/L or haemoglobin < 80 g/L, if already available.
- Known coagulopathic conditions, including but not limited to:
- Activated protein C (APC) resistance,
- Hemophilia A or B,
Show all 10Show fewer
- Vitamin K deficiency,
- Disseminated intravascular coagulation (DIC),
- Antiphospholipid syndrome,
- von Willebrand disease, Other known congenital or acquired bleeding disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contact Activation of Coagulation in Newly Inserted Central Catheters - a Randomized Controlled Trial
A central venous catheter (CVC) is a thin plastic tube placed into one of the body's large veins, typically in the neck or near the clavicle. CVCs are crucial for administering medications, fluids, and secure blood samples. Although CVCs are an essential tool in healthcare, there are certain risks and complications associated with their use. CVCs can affect the body's coagulation system, potentially leading to the formation of blood clots at the site of the catheter. This can result in serious complications, and in some cases, increased morbidity and mortality. Despite the known risk of blood clot formation with catheter use, it is still do not fully understand why clots occur or how a newly inserted catheter affects the coagulation system.
The aim of this randomized controlled trial is to compare four different central venous catheters and their impact on the coagulation system.
Read more
Eighty eight patients ≥18 years of age, who require a CVC and agree to participate in the study will be randomly assigned to one of the four predetermined, commonly used, central venous catheters. Two blood samples will be taken from the newly inserted catheter. The first blood sample (Sample 1) will be collected within seconds after catheter insertion without pre-flushing the catheter with saline. The second blood sample (Sample 2) will be taken after the catheter has been flushed with at least 10 ml saline and the initial blood discarded. All samples will be taken from the distale lumen without any connectors. Samples 1 and 2 will then be analyzed to measure how the coagulation system is affected after contact with the inside surface of the CVC. The blood samples will also be compared between the different catheter types and in overall cohort irrespective of group .
The study could provide valuable information on how the coagulation system is affected after catheter insertion. This knowledge could help improve preventive measures to reduce the risk of blood clot formation and ensure safer blood sampling for patients with venous catheters.
Read the detailed description
This is a randomized controlled trial, designed to evaluate coagulation activation in response to four different commercially available central venous catheters (CVCs), all with similar internal surface areas. The study focuses on comparing changes in coagulation parameters, primarily clotting time (CT), measured using rotational thromboelastometry (ROTEM® NATEM), as well as additional ROTEM variables and standard coagulation markers.
Participants are included based on clinical need for central venous access, and are randomized using REDCap to receive one of four CVC types:
- MERITMEDICAL Careflow™ Two-Lumen Catheter (7 Fr, 150 mm, polyurethane, OD 2.4 mm)
- ARROW Two-Lumen Catheter (7 Fr, 160 mm, polyurethane, OD 2.5 mm)
- ARROWg+ard Blue Plus® Two-Lumen Catheter (8 Fr, 160 mm, polyurethane, OD 2.8 mm, chlorhexidine/silver sulfadiazine coating)
- Multicath 2 Expert UP Two-Lumen Catheter (7.5 Fr, 160 mm, polyurethane shaft embedded with silver ions, OD 2.5 mm)
Blood samples will be collected at two time points for each participant:
- Sample 1: Immediately after catheter insertion, before flushing
- Sample 2: After at least 10 ml saline flush and discard protocol
All catheters will be inserted without pre-procedural filling with saline.
Blood will be collected into Vacuette® CTAD tubes (Greiner Bio-One, Kremsmünster, Austria) containing sodium citrate, theophylline, adenosine, and dipyridamole, designed for hemostatic testing. The tubes will be inverted eight times immediately after blood collection and kept at 37°C until processing. ROTEM® analysis will be performed within 3 hours of blood collection. After the ROTEM® analysis, the remaining blood will undergo centrifugation at 4000g for 15 minutes, and 600-700 µL of plasma from each sample will be transferred into cryotubes, which will be immediately frozen and stored at -80°C for further analysis.
Laboratory and ROTEM® Analyses
ROTEM® analyses will be performed on whole blood using recalcified non-activated thromboelastometry (NATEM), in accordance with the manufacturer's instructions. Each test will be run for 60 minutes, measuring the following variables:
Clotting Time (CT) - time to initial fibrin formation Clot Formation Time (CFT) - speed of thrombus development Alpha Angle (α-angle) - kinetics of clot formation Maximum Clot Firmness (MCF) - measure of final clot strength
Routine Plasma-Based Coagulation Assays:
Prothrombin Time-International Normalized Ratio (PT-INR) Activated Partial Thromboplastin Time (aPTT)
The following coagulation markers will also be assessed:
Factor VII (FVII) and Factor XII (FXII) Thrombin-Antithrombin Complex (TAT)
- Conditions
- Central Venous Catheter, Coagulation, Coagulation Activation, Central Venous Catheter Complications
- Being tested
- MERITMEDICAL Careflow™ Two-Lumen Central Venous Catheter, ARROW Two-Lumen Central Venous Catheter, ARROWg+ard Blue Plus® Two-Lumen Central Venous Catheter, Multicath 2 Expert UP Two-Lumen Central Venous Catheter
- Keywords
- coagulation, ROTEM, central venous catheter
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MERITMEDICAL Careflow™ Two-Lumen Central Venous CatheterDevice
7 Fr, 150 mm, radio-opaque polyurethane catheter (OD 2.4 mm)
ARROW Two-Lumen Central Venous CatheterDevice
7 Fr, 160 mm, radio-opaque polyurethane catheter (OD 2.5 mm)
ARROWg+ard Blue Plus® Two-Lumen Central Venous CatheterDevice
8 Fr, 160 mm, radio-opaque polyurethane catheter with antimicrobial coating
Multicath 2 Expert UP Two-Lumen Central Venous CatheterDevice
7.5 Fr, 160 mm, central venous catheter (OD 2.5 mm). Polyurethane shaft embedded with silver ions.
| Study group | Role | What they receive |
|---|---|---|
| Group A: MERITMEDICAL Careflow™ | Active comparator | Participants will receive a MERITMEDICAL Careflow™ two-lumen 7 Fr, 150 mm, polyurethane central venous catheter (OD 2.4 mm). Receives: Device: MERITMEDICAL Careflow™ Two-Lumen Central Venous Catheter |
| Group B: ARROW | Active comparator | Participants will receive an ARROW two-lumen 7 Fr, 160 mm, polyurethane central venous catheter (OD 2.5 mm). Receives: Device: ARROW Two-Lumen Central Venous Catheter |
| Group C: ARROWg+ard Blue Plus® | Active comparator | Participants will receive an ARROWg+ard Blue Plus® two-lumen 8 Fr, 160 mm, polyurethane catheter (OD 2.8 mm) with chlorhexidine and silver sulfadiazine coating. Receives: Device: ARROWg+ard Blue Plus® Two-Lumen Central Venous Catheter |
| Group D: Multicath 2 Expert UP | Active comparator | Participants will receive a Multicath 2 Expert UP two-lumen 7.5 Fr, 160 mm, polyurethane shaft embedded with silver ions (OD 2.5 mm). Receives: Device: Multicath 2 Expert UP Two-Lumen Central Venous Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ROTEM NATEM Clotting Time (CT) (seconds) between Sample 1 and Sample 2
The primary endpoint is the difference in clotting time (CT), measured using ROTEM NATEM, between two blood samples collected from each participant. Sample 1 is collected immediately after catheter insertion, and Sample 2 is collected after a standardized flush and discard procedure. The change in CT will be compared across the four catheter groups to evaluate differences in coagulation activation.
Measured: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Secondary outcomes (9)
Change in ROTEM NATEM CT between Sample 1 and Sample 2: within-group and overall cohort comparisons.
Change in ROTEM NATEM CT between Sample 1 and Sample 2: within-group and overall cohort comparisons.
Measured: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in ROTEM NATEM Clot Formation Time (CFT) (seconds) between Sample 1 and Sample 2
Between-group comparison of the change in ROTEM NATEM Clot Formation Time (ΔCFT) (seconds) between Sample 1 and Sample 2, with within-group comparisons of CFT and an overall cohort comparison of Sample 1 versus Sample 2.
Measured: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in ROTEM Alpha Angle (α-angle) (degrees) between Sample 1 and Sample 2
Between-group comparison of the change in ROTEM NATEM Alpha Angle (Δα-angle, degrees) between Sample 1 and Sample 2, with within-group comparisons of α-angle and an overall cohort comparison of Sample 1 versus Sample 2.
Measured: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in ROTEM Maximum Clot Firmness (MCF) (mm) between Sample 1 and Sample 2
Between-group comparison of the change in ROTEM NATEM Maximum Clot Firmness (MCF) (mm) between Sample 1 and Sample 2, with within-group comparisons of MCF and an overall cohort comparison of Sample 1 versus Sample 2.
Measured: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in Prothrombin Time - International Normalized Ratio (PT-INR) (continous unitless variable) between Sample 1 and Sample 2
Between-group comparison of the change in Prothrombin Time - International Normalized Ratio (PT-INR) between Sample 1 and Sample 2, with within-group comparisons of PT-INR and an overall cohort comparison of Sample 1 versus Sample 2.
Measured: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in Activated Partial Thromboplastin Time (aPTT) (seconds) between Sample 1 and Sample 2
Between-group comparison of the change in Activated Partial Thromboplastin Time (aPTT) (seconds) between Sample 1 and Sample 2, with within-group comparisons of aPTT and an overall cohort comparison of Sample 1 versus Sample 2.
Measured: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in Factor VII Activity (FVII) (kIU/L) between Sample 1 and Sample 2
Between-group comparison of the change in Factor VII Activity (FVII) (kIU/L) between Sample 1 and Sample 2, with within-group comparisons of FVII and an overall cohort comparison of Sample 1 versus Sample 2.
Measured: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in Factor XII Activity (FXII) (kIU/L) between Sample 1 and Sample 2
Between-group comparison of the change in Factor XII Activity (FXII) (kIU/L) between Sample 1 and Sample 2, with within-group comparisons of FXII and an overall cohort comparison of Sample 1 versus Sample 2.
Measured: Time Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in Thrombin-Antithrombin Complex Concentration (TAT) (mikrogr/L) between Sample 1 and Sample 2
Between-group comparison of the change in Thrombin-Antithrombin Complex Concentration (TAT) (mikrogr/L) between Sample 1 and Sample 2, with within-group comparisons of TAT and an overall cohort comparison of Sample 1 versus Sample 2.
Measured: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start10 Sep 2025
- Primary completion15 May 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Venous CatheterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Kander
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor-investigator, Thomas Kander, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014722
- Sponsor's protocol ID
- CAS-2
- Acronym
- CAS-2
- Status last verified
- Sep 2026
- First submitted
- 12 May 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the study results will be made available upon reasonable request. Data will be completely anonymized prior to sharing, in accordance with applicable data protection regulations. Requests from both academic researchers and commercial entities (e.g., device manufacturers) will be considered. All requests will undergo review to assess scientific validity and compliance with ethical standards.
Publications
Zorlak A, Naddi L, Borgquist O, Kander T. Contact activation of coagulation in newly inserted central venous catheters (CAS-2): protocol for a randomised controlled study comparing four commercially available catheters. BMJ Open. 2026 Jun 28;16(6):e119213. doi: 10.1136/bmjopen-2026-119213.
PubMed 42366009
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contact Activation of Coagulation in Newly Inserted Central Catheters - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07014722
- Acronym / sponsor ID
- CAS-2 / CAS-2
- Conditions
- Central Venous Catheter, Coagulation, Coagulation Activation, Central Venous Catheter Complications
- Keywords
- coagulation, ROTEM, central venous catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Thomas KanderUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A central venous catheter (CVC) is a thin plastic tube placed into one of the body's large veins, typically in the neck or near the clavicle. CVCs are crucial for administering medications, fluids, and secure blood samples. Although CVCs are an essential tool in healthcare, there are certain risks and complications associated with their use. CVCs can affect the body's coagulation system, potentially leading to the formation of blood clots at the site of the catheter. This can result in serious complications, and in some cases, increased morbidity and mortality. Despite the known risk of blood clot formation with catheter use, it is still do not fully understand why clots occur or how a newly inserted catheter affects the coagulation system.
The aim of this randomized controlled trial is to compare four different central venous catheters and their impact on the coagulation system.
Eighty eight patients ≥18 years of age, who require a CVC and agree to participate in the study will be randomly assigned to one of the four predetermined, commonly used, central venous catheters. Two blood samples will be taken from the newly inserted catheter. The first blood sample (Sample 1) will be collected within seconds after catheter insertion without pre-flushing the catheter with saline. The second blood sample (Sample 2) will be taken after the catheter has been flushed with at least 10 ml saline and the initial blood discarded. All samples will be taken from the distale lumen without any connectors. Samples 1 and 2 will then be analyzed to measure how the coagulation system is affected after contact with the inside surface of the CVC. The blood samples will also be compared between the different catheter types and in overall cohort irrespective of group .
The study could provide valuable information on how the coagulation system is affected after catheter insertion. This knowledge could help improve preventive measures to reduce the risk of blood clot formation and ensure safer blood sampling for patients with venous catheters.
Detailed description
This is a randomized controlled trial, designed to evaluate coagulation activation in response to four different commercially available central venous catheters (CVCs), all with similar internal surface areas. The study focuses on comparing changes in coagulation parameters, primarily clotting time (CT), measured using rotational thromboelastometry (ROTEM® NATEM), as well as additional ROTEM variables and standard coagulation markers.
Participants are included based on clinical need for central venous access, and are randomized using REDCap to receive one of four CVC types:
- MERITMEDICAL Careflow™ Two-Lumen Catheter (7 Fr, 150 mm, polyurethane, OD 2.4 mm)
- ARROW Two-Lumen Catheter (7 Fr, 160 mm, polyurethane, OD 2.5 mm)
- ARROWg+ard Blue Plus® Two-Lumen Catheter (8 Fr, 160 mm, polyurethane, OD 2.8 mm, chlorhexidine/silver sulfadiazine coating)
- Multicath 2 Expert UP Two-Lumen Catheter (7.5 Fr, 160 mm, polyurethane shaft embedded with silver ions, OD 2.5 mm)
Blood samples will be collected at two time points for each participant:
- Sample 1: Immediately after catheter insertion, before flushing
- Sample 2: After at least 10 ml saline flush and discard protocol
All catheters will be inserted without pre-procedural filling with saline.
Blood will be collected into Vacuette® CTAD tubes (Greiner Bio-One, Kremsmünster, Austria) containing sodium citrate, theophylline, adenosine, and dipyridamole, designed for hemostatic testing. The tubes will be inverted eight times immediately after blood collection and kept at 37°C until processing. ROTEM® analysis will be performed within 3 hours of blood collection. After the ROTEM® analysis, the remaining blood will undergo centrifugation at 4000g for 15 minutes, and 600-700 µL of plasma from each sample will be transferred into cryotubes, which will be immediately frozen and stored at -80°C for further analysis.
Laboratory and ROTEM® Analyses
ROTEM® analyses will be performed on whole blood using recalcified non-activated thromboelastometry (NATEM), in accordance with the manufacturer's instructions. Each test will be run for 60 minutes, measuring the following variables:
Clotting Time (CT) - time to initial fibrin formation Clot Formation Time (CFT) - speed of thrombus development Alpha Angle (α-angle) - kinetics of clot formation Maximum Clot Firmness (MCF) - measure of final clot strength
Routine Plasma-Based Coagulation Assays:
Prothrombin Time-International Normalized Ratio (PT-INR) Activated Partial Thromboplastin Time (aPTT)
The following coagulation markers will also be assessed:
Factor VII (FVII) and Factor XII (FXII) Thrombin-Antithrombin Complex (TAT)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: MERITMEDICAL Careflow™ | Active comparator | Device: MERITMEDICAL Careflow™ Two-Lumen Central Venous CatheterParticipants will receive a MERITMEDICAL Careflow™ two-lumen 7 Fr, 150 mm, polyurethane central venous catheter (OD 2.4 mm). |
| Group B: ARROW | Active comparator | Device: ARROW Two-Lumen Central Venous CatheterParticipants will receive an ARROW two-lumen 7 Fr, 160 mm, polyurethane central venous catheter (OD 2.5 mm). |
| Group C: ARROWg+ard Blue Plus® | Active comparator | Device: ARROWg+ard Blue Plus® Two-Lumen Central Venous CatheterParticipants will receive an ARROWg+ard Blue Plus® two-lumen 8 Fr, 160 mm, polyurethane catheter (OD 2.8 mm) with chlorhexidine and silver sulfadiazine coating. |
| Group D: Multicath 2 Expert UP | Active comparator | Device: Multicath 2 Expert UP Two-Lumen Central Venous CatheterParticipants will receive a Multicath 2 Expert UP two-lumen 7.5 Fr, 160 mm, polyurethane shaft embedded with silver ions (OD 2.5 mm). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical indication for the placement of a two-lumen central venous catheter with length 150-160 mm.
- Age ≥18 years.
- Signed informed consent.
Key exclusion criteria (10 listed)
- Current use of anticoagulants or platelet inhibitors, except: Prophylactic low molecular weight heparin (LMWH), double prophylactic dose of LMWH, Acetylsalicylic acid (ASA).
- Prothrombin complex (pK/INR) outside the normal range (0.9-1.2), platelet count <50 × 10⁹/L or haemoglobin < 80 g/L, if already available.
- Known coagulopathic conditions, including but not limited to:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MERITMEDICAL Careflow™ Two-Lumen Central Venous Catheter7 Fr, 150 mm, radio-opaque polyurethane catheter (OD 2.4 mm) | Device | Group A: MERITMEDICAL Careflow™ |
| ARROW Two-Lumen Central Venous Catheter7 Fr, 160 mm, radio-opaque polyurethane catheter (OD 2.5 mm) | Device | Group B: ARROW |
| ARROWg+ard Blue Plus® Two-Lumen Central Venous Catheter8 Fr, 160 mm, radio-opaque polyurethane catheter with antimicrobial coating | Device | Group C: ARROWg+ard Blue Plus® |
| Multicath 2 Expert UP Two-Lumen Central Venous Catheter7.5 Fr, 160 mm, central venous catheter (OD 2.5 mm). Polyurethane shaft embedded with silver ions. | Device | Group D: Multicath 2 Expert UP |
Primary outcome
Change in ROTEM NATEM Clotting Time (CT) (seconds) between Sample 1 and Sample 2
Time frame: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
The primary endpoint is the difference in clotting time (CT), measured using ROTEM NATEM, between two blood samples collected from each participant. Sample 1 is collected immediately after catheter insertion, and Sample 2 is collected after a standardized flush and discard procedure. The change in CT will be compared across the four catheter groups to evaluate differences in coagulation activation.
9 secondary outcomes
Change in ROTEM NATEM CT between Sample 1 and Sample 2: within-group and overall cohort comparisons.
Time frame: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in ROTEM NATEM Clot Formation Time (CFT) (seconds) between Sample 1 and Sample 2
Time frame: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in ROTEM Alpha Angle (α-angle) (degrees) between Sample 1 and Sample 2
Time frame: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in ROTEM Maximum Clot Firmness (MCF) (mm) between Sample 1 and Sample 2
Time frame: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in Prothrombin Time - International Normalized Ratio (PT-INR) (continous unitless variable) between Sample 1 and Sample 2
Time frame: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in Activated Partial Thromboplastin Time (aPTT) (seconds) between Sample 1 and Sample 2
Time frame: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in Factor VII Activity (FVII) (kIU/L) between Sample 1 and Sample 2
Time frame: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in Factor XII Activity (FXII) (kIU/L) between Sample 1 and Sample 2
Time frame: Time Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in Thrombin-Antithrombin Complex Concentration (TAT) (mikrogr/L) between Sample 1 and Sample 2
Time frame: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Derived from this study: PubMed 42366009Zorlak A, Naddi L, Borgquist O, Kander T. Contact activation of coagulation in newly inserted central venous catheters (CAS-2): protocol for a randomised controlled study comparing four commercially available catheters. BMJ Open. 2026 Jun 28;16(6):e119213. doi: 10.1136/bmjopen-2026-119213.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the study results will be made available upon reasonable request. Data will be completely anonymized prior to sharing, in accordance with applicable data protection regulations. Requests from both academic researchers and commercial entities (e.g., device manufacturers) will be considered. All requests will undergo review to assess scientific validity and compliance with ethical standards.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MERITMEDICAL Careflow™ Two-Lumen Central Venous Catheter, ARROW Two-Lumen Central Venous Catheter and ARROWg+ard Blue Plus® Two-Lumen Central Venous Catheter in people with Central Venous Catheter and Coagulation, run by Thomas Kander at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ROTEM NATEM Clotting Time (CT) (seconds) between Sample 1 and Sample 2 (time frame: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07014722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.